CMC Regulatory Affairs Associate, AstraZeneca, Södertälje

Job description
CMC Regulatory Affairs Associate, Global Regulatory Excellence

Are you an organized and detail-oriented person who enjoys working with documentation? Do you have experience from working with quality in the pharmaceutical industry?  This might be the next challenge for you!

CMC Regulatory Affairs is a global function that manages all Chemistry, Manufacturing and Controls (CMC) regulatory activities across AstraZeneca’s global supply chain. We are looking for CMC Regulatory Affairs Associates to join our CMC team focused on divestment related activities located in Södertälje. 

We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of an extraordinary place to work; an environment that energizes and empowers each of us to support compliant product supply through partnership with other AZ teams.

As a consultant at Randstad Life Sciences, we are your employer, but you have your daily workplace with one of our customers. Your consulting manager is always close at hand, both during and between assignments to help you develop your career in the direction you dream of. As a consultant with us, you get a competitive salary, benefits and collectively agreed terms. We are responsive to your wishes regarding assignments and tasks and with our broad customer portfolio in Mälardalen, we will together adapt your continued career according to your skills, experience and ambition. At Randstad Life Sciences, we have an offer that means that you have the opportunity to develop your skills and / or take extra time off after you have been with us for a while. You will be part of a larger consulting team within Life Sciences and have the opportunity to broaden your network and gain valuable experience from different workplaces.

Responsibilities
The role

As a CMC Regulatory Affairs Associate you will generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status. You will support externalisation projects where transfer of CMC documentation to external partners is an important and regular task. 

You will work with colleagues and other functions within AstraZeneca as well as external partners to obtain information that supports the generation of regulatory CMC documentation.

Qualifications
Minimum Requirements - Education and Experience
• Degree in Chemistry or Pharmacy or Chemical Engineering, or equivalent experience
• Fluently spoken and written English and Swedish
• Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs

Skills and Capabilities
• Experience from and interest of using Document Management systems
• Attention to details, highly organized, able to plan and control own workload effectively and manage expectation of others
• Ability to work with short and / or changing timelines
• Able to work collaboratively with customers and colleagues to achieve optimum outcomes
• High level understanding of GMP and working in a regulated environment
• High level understanding of CMC Regulatory
• Excellent written and verbal communication skills
• IT software skills

Application
Deadline: 2022-05-28. Selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible. We do not accept applications through email.

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many activities.

Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!